Subpart H - HUMANITARIAN USE DEVICES
- Section 814.100 - Purpose and scope
- Section 814.102 - Designation of HUD status
- Section 814.104 - Original applications
- Section 814.106 - HDE amendments and resubmitted HDE's
- Section 814.108 - Supplemental applications
- Section 814.110 - New indications for use
- Section 814.112 - Filing an HDE
- Section 814.114 - Timeframes for reviewing an HDE
- Section 814.116 - Procedures for review of an HDE
- Section 814.118 - Denial of approval or withdrawal of approval of an HDE
- Section 814.120 - Temporary suspension of approval of an HDE
- Section 814.122 - Confidentiality of data and information
- Section 814.124 - Institutional Review Board requirements
- Section 814.126 - Postapproval requirements and reports